Recall Z-0995-2007 ยท HNN Knife, Ophthalmic
Oasis Medical Inc
Premier Edge MVR 19g Microsurgical Knife, Item PE-3519
| Date | Jul 4, 2007 (initiated Jun 8, 2007) |
| Status | Terminated |
| Reason | This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. |
| Root cause | Device Design |
| Action | Notification of the recall sent to distributors and users. The 06/08/07 letter requests customers to notify down to the user level. Included in the Recall Notification Letter are instructions: "In addition, if you may have further distributed this product, please identify your customers and notify them at once ofthis product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any inconvenience." |
| Distribution | Worldwide, including USA, Switzerland, Germany, England, UK, Turkey, Czech Republic, and Lithuania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.